Health claim and evidence in health food in Japan: vocabulary and law International Conference and Exhibition on Nutraceuticals and Functional Foods (ISNFF) 2011 16 November 2011, Sapporo, Japan Kiichiro TSUTANI MD, PhD 津谷喜一郎 Dept. of Drug Policy and Management, Graduate School of Pharmaceutical Sciences, The University of Tokyo 1 Health Technology Assessment Report of Glucosamine National Evidence-based Healthcare Collaborating Agency (NECA), Seoul, 2010 By systematic review, that there was lack of data to reach conclusions that glucosamine is effective for treatment and prevention of osteoarthritis . Bae SC. Glucosamine and chondroitin products: Are they being used appropriately?: NECA News letter 2 EVIDENCE & VALUE 29. Sep. 2010; 20-1 http://neca.re.kr/ebook/vol4/eng/vol4_eng_all/EBook.htm 1
Dr. Dae Seog HEO, SNU Glucosamine not as “active ingredient”( 有効成分 ) in OTC drug in Japan, but as “additive” ( 添加剤 ) 4 2
Same brand name “Flexpower” in both as OTC drug and “so-called” health food 健康補助⾷品 OTC drug ( “ health supplementary food ” ) (No information of glucos- A kind of “so-called” health food amine in the label) 5 “ 栄養補助食品 ”(Nutritional supplementary food) as “so-called” health food Image: knee pain Words: Sitting, standing and walking Questions: - What is people’s perception of this product ? 6 - How people recognize this product ? 3
Ethical glucosamine in ROK 7 Package insert of Ethical glucosamine in ROK 8 4
OTC Reimbursed by national health insurance in ROK 亜州薬品工業株式会社 Glucosamine OTC Not reimbursed by national health insurance in ROK Binex 株式会社 5
Glucosamine: same evidence, different policies Drug Food ethical OTC Reimb No Italia Germany Japan (health food) ursem England Scotland U.S.A. (dietary supplement) ent Sweden Canada (nutritional product) Ireland Austria (complementary medicine) Korea Malaysia (health supplement) Singapore (health supplement) Korea (health supplement) Yes Korea Korea Taiwan Thailand Dr. Dae Seog HEO, SNU and revised by TSUTANI K My findings • Different regulatory categories on same evidence exists even in one country • Different words and/or graphic image appeals “health claim” • Rich vocabulary and image ! • Need people’s perception study • “How people distinguish “true” health claim from fake/quasi health claim ?” 6
Requirements for physiological conditions of subjects for human clinical study for FOSHU （１） Cholesterol Total cholesterol in serum is essentially be between 200 ～ 240mg/dL 、 and LDL cholesterol must be between 120 ～ 160mg/dL ; duration of study must be longer than 12 weeks （２） Triglyceride Triglyceride in serum is better to be somewhat higher those of rule and between 120 ～ 200mg/dL of fasting subjects and the study is continued for at least 12 weeks （３） Blood pressure Essentially, subjects with normal higher blood pressure, low risk and middle risk high blood pressures are objects and the study is continued longer than 12 weeks （４） Blood sugar According to the criteria, the fasting blood sugar levels are judged as bordering type diabetes or bordering by sugar loading. Study should be continued for longer than 12 weeks （５） Body Fat The study must be carried out separately between male and female and classified depended on ages, and obesity criteria is 1 according to the Japan Obesity Society （ BMI 25 ≦ ～＜ 30 ） . The study must be carried out for longer than 12 weeks Requirements for clinical studies for FOSHU • Randomized placebo controlled study • Subject number must be meet to statistically significance (probably n = 100 – 200) • Enough duration of study to obtain the statistically significant difference ( ≥ three months) • Clear endpoints • Exclude children, pregnant • Sample must be identical to the product which will be on market • P-value for statistical analysis must be less than 5% • All clinical studies must be carried out according to Helsinki Declaration • Approval by the Ethical Committee 14 7
Regulatory Systems of Health Claims in Japan. Food Labeling Division, Consumer Affairs 15 Agency (CAA), June 2011 http://www.caa.go.jp/en/pdf/syokuhin338.pdf Example 1 Model claim: Helps lower cholesterol level . 「本品は、コレステロールの吸収を抑え、血中コレステロールを 低下させる働きのあるキトサンを配合しています。コレステロー ル値が高めの方や気になる方の食生活の改善に役立ちます。」 “Good for improving dietary habit for those having relatively high serum cholesterol level or those concerning cholesterol level” 16 8
Example 2 Model claim: For those with high blood pressure . 「本品はゴマペプチドを含んでおり、血圧が 高めの方に適した飲料です。」 “Good for those having relatively high blood pressure” 17 Example 3-1 Model claim: Promote calcium absorption. Supports bone health 「本品はフラクトオリゴ糖の作用により、丈 夫な骨をつくるカルシウムの吸収が促進さ れるよう工夫された飲料です。」 “Make bone strong by efficient calcium absorption ” 18 9
Example 3-2 Model claim: Promote calcium absorption. Supports bone health 「この食品はカルシウムを豊富に含みます。 日頃の運動と適切な量のカルシウムを含む 健康的な食事は、若い女性が健全な骨の健 康を維持し、歳をとってからの骨粗鬆症にな るリスクを低減するかもしれません。」 “Daily exercise and healthy diet containing adequate dose of calcium maintain bone health and may reduce risk of osteoporosis in the elderly age. ” 19 Example 3-3 Model claim: Promote calcium absorption. Supports bone health 「この食品はカルシウムを豊富に含みます。 日頃の運動と適切な量のカルシウムを含む 健康的な食事は、若い女性が健全な骨の健 康を維持し、歳をとってからの骨粗鬆症にな るリスクを低減するかもしれません。」 “Daily exercise and healthy diet containing adequate dose of calcium maintain bone health and may reduce risk of osteoporosis in the elderly age. ” 20 10
Disease Risk Reduction Claim • Evidences must be based on the comprehensive and intensive researches of published scientific papers and results from published meta-analysis are also submitted. • Disease risk reduction claims should be are strongly related to the domestic nutritional circumstances • Applications of Disease risk reduction claims and FOSHU must be simultaneously done Notification Shokuanhatsu 0201003, 2007 Feb.1 21 Recognized Disease Risk Reduction Claims of FOSHU Disease risk reduction claims are permitted to FOSHU products with conditions shown below. Permission of claiming disease risk reduction are limited to calcium and folic acid. Calcium ： Calcium Daily intake of calcium from FOSHU products should be included between 300mg and 700 mg Claim ： This product contains calcium in abundance. Intake of appropriate amount of calcium contained in healthy meals with appropriate exercise supports health of bones of young women and may reduce the risk of osteoporosis when aged. 13/967 (as of 13 Oct 2011) Folic Acid ： Folic acid Daily intake of folic acid from FOSHU products should be included between 400 ㎍ and 1,000 ㎍ Claim ： This product contains folic acid abundance. Healthy meals containing appropriate amount of folic acid may supports women to bear healthy baby by reduction of risk of neural tube defect such as spondyloschisis. 22 0/967 (as of 13 Oct 2011) 11
Various categorical terms have no legal basis Legal base 1) Food for Specified Health Uses (FOSHU, 特定保健用食品 ); 2) Food with Nutrient Functional Claims （ FNFC, 栄養機能食品 ); 3) Food for Special Dietary Uses (FOSDU, 特別用途食品 ) No legal base health food ( 健康食品 ), health supplementary food ( 健康補助食 品 ), nutritional supplementary food( 栄養補助食品 ), nutritional strengthened food( 栄養強化食品 ), nutritional regulating food( 栄養 調整食品 ), health drink( 健康飲料） , “sapurimento”( サプリメント） Rich vocabulary ! But problem in Japan is that market of so-called “health food” is 23 so large. 12
PICO in EBM: defining problem Patient : young female Intervention: calcium rich food Control : non-treatment Outcome : bone density or fracture “prevention of osteoporosis ” risk reduction of disease In Japan • In risk reduction health claim, word is simple and easy to understand. Poor vocabulary. • But in “structure and function claim” in so-called health foods, there are lots of words, which is difficult to understand. Rich vocabulary. • Why ? • Problems in regulation in “structure and function claim” 13
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